Assessment of PPG & PAT to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea

April 9, 2013 updated by: Sotera Wireless, Inc.

Assessment of a New Photoplethysmographic (PPG) Method and a Pulse Arrival Time Method to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in a Sleep Laboratory

The goal of this study is to collect raw waveform data for two separate noninvasive methods, both of which may be useful for the assessment of upper airway obstruction.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Escondido, California, United States, 92029
        • Palomar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients twenty-one years of age or older

Exclusion Criteria:

  • Patient refusal to participate in study
  • Patients under 21 (twenty-one) years of age,
  • Referring physician's refusal to have his/her patient participate in the study.
  • Patients with cardiac dysrhythmia (arrhythmia), including atrial fibrillation, and frequent premature atrial and/or ventricular contractions.
  • Inability to obtain a Sotera cuff pressure and/or PPG signals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Measurement of PPG waveforms
Collection of photoplethysmograph(PPG)waveform data from patients with obstructive sleep apnea for 4-8 hours
Device: Measurement of PPG waveforms
The ViSi Vital Signs Monitor will measure PPG waveforms for 4 hours.
Other Names:
  • ViSi Monitor
Experimental: Measurement of Pulse Arrival Time (PAT)
Collection of PAT waveform data from patients with obstructive sleep apnea for 4-8 hours
Device: Measurement of Pulse Arrival Time (PAT)
The ViSi Vital Signs Monitor will measure PAT waveforms for 4 hours.
Other Names:
  • ViSi Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of pulse arrival time in patients with obstructive sleep apnea syndrome.
Time Frame: 4 - 8 hours
The goal of this study is to collect pulse arrival time data as a means for the assessment of upper airway obstruction.
4 - 8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-invasive Photoplethysmographic (PPG) measurement in patients with obstructive sleep apnea syndrome.
Time Frame: 4 - 8 hours
The goal of this study is to collect PPG waveforms as a means for the assessment of upper airway obstruction.
4 - 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sotera Wireless, Inc.

Investigators

  • Study Director: James Welch, MS, Sotera Wireless

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Estimate)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-01 (Other Identifier: AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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